Shionogi-ViiV Healthcare announces completion of initial clinical registration package for dolutegravir in HIV

Shionogi-ViiV Healthcare LLC today announced that the phase III data required for initial regulatory filings of the investigational integrase inhibitor dolutegravir in adults infected with HIV are in house. Data from the two phase III studies in treatment-experienced patients (VIKING-3 and SAILING) have been received and will be the subject of future presentations at scientific meetings. Together with previously disclosed data from the SPRING-2 and SINGLE studies in treatment-naive patients, these additional study data support Shionogi-ViiV Healthcare’s plans to commence global regulatory submissions for dolutegravir before the end of 2012. Dolutegravir is not yet approved as a treatment for HIV or any other indication anywhere in the world.

About the VIKING-3 and SAILING studies in treatment-experienced adults with HIV-1

VIKING-3 (ING112574) is an ongoing Phase III, multicentre, open-label, single arm study to assess the antiviral activity and safety of dolutegravir 50mg twice-daily in treatment-experienced adults with HIV-1 and historical or current evidence of resistance to raltegravir or elvitegravir.

SAILING (ING111762) is an ongoing Phase III, multicentre, double blind, double dummy study to compare the efficacy and safety of dolutegravir 50mg once-daily to raltegravir 400mg twice-daily in treatment-experienced, integrase inhibitor-naive adults with HIV-1.

The full results of these studies will be presented at upcoming scientific meetings.

About the SPRING-2 and SINGLE studies in treatment-naive adults with HIV-1

SPRING-2(ING113086)is an ongoing Phase III, multicentre, double blind, double dummy study to compare the efficacy and safety of dolutegravir 50mg once-daily to raltegravir 400mg twice-daily in treatment-naïve adults with HIV-1.Full 48-week data from SPRING-2 were presented at the International AIDS Conference in July 2012.

SINGLE (ING114467) is an ongoing Phase III, multicentre, double blind, double dummy study to compare the efficacy and safety of once-daily dolutegravir 50mg plus abacavir/lamivudine versus Atripla (tenofovir/emtricitabine/efavirenz). Full 48-week data from SINGLE were presented at ICAAC in September 2012. Together with data from an ongoing bioequivalence study (ING114580) , SINGLE is designed to support additional regulatory submissions for a fixed dose combination of dolutegravir/abacavir/lamivudine.

About Dolutegravir

S/GSK1349572 (dolutegravir) is an investigational integrase inhibitor (INI) currently in development by Shionogi-ViiV Healthcare LLC for the treatment of HIV for use in combination with other HIV medicines. Dolutegravir is being evaluated for safety and efficacy without an additional ‘booster’ drug being added to the regimen. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Given the stage of development of this investigational HIV therapy, the full picture of the efficacy and safety of dolutegravir has not been conclusively determined.